Phase 3 Study of Toripalimab Alone or in Combination With Tifcemalimab as Consolidation Therapy in Patients With Limited-stage Small Cell Lung Cancer (LS-SCLC)
This research study is for people who have been diagnosed with limited-stage small cell lung cancer. This type of cancer is currently treated with chemotherapy and radiation. The study aims to find out if giving two new medications, called toripalimab and tifcemalimab, either on their own or together, after a person has finished their initial chemotherapy and radiation treatment, can help reduce the chance of the cancer growing or coming back. These new drugs are a type of immunotherapy, meaning they work with your body's immune system. Participants will be randomly assigned to receive one of the study drugs or a placebo (a dummy drug). The study wants to see how safe and effective these new treatments are.
At a glance
What is this study about?
This study is focused on a specific type of lung cancer called limited-stage small cell lung cancer. After receiving standard treatment such as chemotherapy and radiation, people with this type of cancer sometimes find that the cancer can return or start to grow again. This study is trying to find a way to prevent that from happening by adding another treatment called "consolidation therapy."
The study will look at two new drugs, toripalimab and tifcemalimab. These drugs are a type of treatment called immunotherapies. Immunotherapy works by helping your own body's immune system fight the cancer. Neither of these drugs is currently approved for treating this specific type of lung cancer, and this study will help doctors learn more about how they work and if they are helpful.
Participants will be divided into groups by chance (like flipping a coin) and will receive either one of the new drugs, a combination of both, or a dummy drug (placebo). This is a 'Phase 3' study, which means it's one of the final stages of testing before a new treatment could potentially become widely available.
Key takeaways
- It's for limited-stage small cell lung cancer patients who have finished standard initial treatment.
- The study tests two new immune-boosting drugs, alone or together, as an extra treatment.
- Participation involves receiving injections and regular check-ups.
- It's a Phase 3 study, one of the final steps in testing new treatments.
- You might receive the active drug or a placebo; neither you nor your doctor will know which.
Who may be eligible?
To join this study, you must be at least 18 years old and have a confirmed diagnosis of limited-stage small cell lung cancer. You must have already completed a standard course of chemotherapy and radiation treatment for your cancer and these treatments should not have caused your cancer to get worse.
Your general health and physical ability should be good, as assessed by the healthcare team. There are also specific requirements regarding your organ function, which the study doctors will check. If you have certain other medical conditions, like some autoimmune diseases, or if you have already received other types of lung cancer treatment beyond your initial chemotherapy and radiation, you might not be able to participate.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years or older?
- Do you have limited-stage small cell lung cancer?
- Have you recently finished chemotherapy and radiation for your lung cancer, and it hasn't progressed?
- Is your general health and physical ability considered good by your doctor?
- Do you have good organ function, as your doctor would assess?
- Do you *not* have a history of serious autoimmune disease?
What does participation involve?
If you decide to take part in this study, you will be given one of the study drugs (toripalimab, tifcemalimab, both, or a placebo) as an injection. This will start within 42 days after your last chemotherapy treatment. The study will involve regular visits to the clinic for treatments, check-ups, and tests to monitor your health and how you are responding to the treatment. These tests might include blood tests and scans. The exact duration of your involvement will depend on the study's plan and how you react to the treatment, but you will have follow-up visits to track your progress. The study doctors and nurses will explain the full schedule to you.
Potential risks and benefits
Locations (156)
- Banner MD Anderson Cancer CenterVerified postcodeGoodyear, United States· Not yet recruiting
- Banner University Medical CenterVerified postcodeTucson, United States· Not yet recruiting
- Genesis Cancer and Blood Institute (Hot Springs, AR)Verified postcodeHot Springs, United States· Not yet recruiting
- SCRI NashvilleVerified postcodeDavis, United States· Not yet recruiting
- Zangmeister Cancer Center (Columbus, OH)Verified postcodeLos Angeles, United States· Not yet recruiting
- Los Angeles Hematology OncologyVerified postcodeLos Angeles, United States· Not yet recruiting
- University of Southern California Norris Comprehensive CancerVerified postcodeLos Angeles, United States· Recruiting
- Florida Cancer Specialists Pan HandleVerified postcodeFort Myers, United States· Not yet recruiting
- Florida Cancer Specialists SouthVerified postcodeFort Myers, United States· Not yet recruiting
- USA029 University of Miami Sylvester Comprehensive Cancer Center 1550 NW 10th Avenue 33173 Miami FL Ikpeazu Chukwuemeka NVerified postcodeMiami, United States· Not yet recruiting
- Mid-Florida Hematology OncologyVerified postcodeOrange City, United States· Recruiting
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb HospitalVerified postcodeMarietta, United States· Not yet recruiting
Common questions
What is 'limited-stage small cell lung cancer'?
This is a type of lung cancer that is usually found only in one lung and nearby lymph nodes, meaning it hasn't spread widely to other parts of the body.
What are 'toripalimab' and 'tifcemalimab'?
These are new immune-boosting drugs (immunotherapies) that are being tested to see if they can help fight this type of lung cancer.
What does 'consolidation therapy' mean?
It's an extra treatment given after your initial chemotherapy and radiation to try and reduce the chance of the cancer coming back.
What is a 'placebo'?
A placebo is a 'dummy' treatment that looks just like the real drug but contains no active medicine. It helps researchers safely compare new treatments.
Will I know which treatment I am getting?
No, this is a 'double-blind' study, meaning neither you nor your doctors will know whether you are receiving the active drug or the placebo. This helps ensure fair results.
How to find out more
kui zhang, Project Directer
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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